Trial Outcomes & Findings for Programs To Support You During Chemotherapy (NCT NCT02489422)
NCT ID: NCT02489422
Last Updated: 2022-10-14
Results Overview
Fatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
At baseline, 8 weeks, 10 weeks and 14 weeks after start of intervention
Results posted on
2022-10-14
Participant Flow
Participant milestones
| Measure |
Group I (Yoga Skills Training)
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Programs To Support You During Chemotherapy
Baseline characteristics by cohort
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
58.5 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline, 8 weeks, 10 weeks and 14 weeks after start of interventionFatigue will be assessed with the 7-item measure of Fatigue from the PROMIS-cancer specifically designed for use in cancer patients. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Score range 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. Total scores can range from 24 to 86, with higher scores indicating greater fatigue.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline
|
53.1 score on a scale
Standard Error 1.8
|
56.8 score on a scale
Standard Error 1.9
|
|
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
8 weeks
|
53.0 score on a scale
Standard Error 2.1
|
57.2 score on a scale
Standard Error 2.2
|
|
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
10 weeks
|
51.1 score on a scale
Standard Error 2.2
|
57.2 score on a scale
Standard Error 2.4
|
|
Fatigue Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)
14 weeks
|
55.4 score on a scale
Standard Error 2.2
|
60.6 score on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: At 0-2 weeks after start of interventionPopulation: Participants analyzed represents the number of participants that completed the analysis and had data for this outcome measure out of the total number of participants for the trial.
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Circadian Disruption (Daily)
|
11.5 days
Standard Error 2.8
|
9.9 days
Standard Error 3.4
|
SECONDARY outcome
Timeframe: At 8-10 weeks after start of interventionPopulation: The number of participants is the actual number that completed this portion of the outcome measure during this timeframe that had measurable data.
Circadian disruption will be assessed with actigraphy. Circadian disruption is defined as a ratio of nighttime activity to daytime activity with higher scores indicating greater circadian disruptions. Summaries of the proportion and frequency of missing daily assessments will inform the feasibility of collecting this type of data.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=21 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=19 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Circadian Disruption (Daily)
|
11.8 days
Standard Deviation 2.3
|
11.9 days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: At baseline, 8 weeks, 10 weeks and 14 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Circadian disruption will be assessed with measures of activity and rest. Activity will be measured using the 3-item Godin's leisure score index (LSI), previously used with colorectal cancer patients during chemotherapy. Rest will be assessed with the 8-item PROMIS sleep disturbance short-form. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Circadian Disruption (Recalled)
Baseline leisure score index (LSI)
|
19.6 score on a scale
Standard Error 5.4
|
19.9 score on a scale
Standard Error 3.6
|
|
Circadian Disruption (Recalled)
8 weeks leisure score index (LSI)
|
24.1 score on a scale
Standard Error 7.1
|
23.9 score on a scale
Standard Error 6.2
|
|
Circadian Disruption (Recalled)
10 weeks leisure score index (LSI)
|
19.8 score on a scale
Standard Error 4.4
|
29.7 score on a scale
Standard Error 12.0
|
|
Circadian Disruption (Recalled)
14 weeks leisure score index
|
24.1 score on a scale
Standard Error 5.5
|
38.1 score on a scale
Standard Error 12.8
|
SECONDARY outcome
Timeframe: At baseline, 8 weeks, 10 weeks and 14 weeks after start of interventionWill be assessed with the standardized 10-item PROMIS-cancer depressive symptoms short-form. These tests will be evaluated using mixed-effects (or multilevel) generalized linear modeling procedures. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive the symptoms. Scores on the short form range from 10 to 81.3; 10-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Depressive Symptoms Assessed by PROMIS
Baseline
|
49.9 score on a scale
Standard Error 1.9
|
51.4 score on a scale
Standard Error 2.0
|
|
Depressive Symptoms Assessed by PROMIS
8 weeks
|
47.4 score on a scale
Standard Error 2.0
|
51.2 score on a scale
Standard Error 2.1
|
|
Depressive Symptoms Assessed by PROMIS
10 weeks
|
46.6 score on a scale
Standard Error 2.3
|
50.5 score on a scale
Standard Error 2.5
|
|
Depressive Symptoms Assessed by PROMIS
14 weeks
|
49.1 score on a scale
Standard Error 2.0
|
50.2 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: At 0-2 weeks and 8-10 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Fatigue will be assessed with 3 items selected from the PROMIS measure of fatigue validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more fatigued the participants. Scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" fatigue.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Fatigue (Daily)
0-2 weeks
|
49.18 score on a scale
Standard Error 1.73
|
53.27 score on a scale
Standard Error 1.92
|
|
Fatigue (Daily)
8-10 weeks
|
51.00 score on a scale
Standard Error 2.06
|
53.29 score on a scale
Standard Error 2.38
|
SECONDARY outcome
Timeframe: At 0-2 weeks and 8-10 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Depressive symptoms will be assessed with 3 items selected from the PROMIS measure of depression validated for use in daily diaries. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. The higher the score the more depressive symptoms the participants exhibited. scores on the short form range from 0 to 81.3; 0-55 is "normal", 55.1-59.9 "mild", 60-64.25 "moderate", and over 64.26 "severe" depression.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Depressive Symptoms (Daily)
0-2 weeks
|
43.96 score on a scale
Standard Error 1.52
|
45.49 score on a scale
Standard Error 1.82
|
|
Depressive Symptoms (Daily)
8-10 weeks
|
44.38 score on a scale
Standard Error 2.36
|
44.58 score on a scale
Standard Error 1.89
|
SECONDARY outcome
Timeframe: At 2 weeks after start of interventionPopulation: The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=13 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
|
5.6 pg/ml
Interval 3.4 to 9.2
|
4.6 pg/ml
Interval 2.8 to 7.8
|
SECONDARY outcome
Timeframe: At 10 weeks after start of interventionPopulation: The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. ). All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=13 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Interleukin 6 [IL-6] Measured Using High-sensitivity Quantikine Immunoassay Kits
|
0.58 pg/ml
Interval 0.38 to 0.9
|
0.58 pg/ml
Interval 0.38 to 0.9
|
SECONDARY outcome
Timeframe: At 2 weeks after start of interventionInflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=13 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
|
1633.8 pg/ml
Interval 1222.1 to 2184.1
|
1727.5 pg/ml
Interval 1281.6 to 2328.6
|
SECONDARY outcome
Timeframe: At 10 weeks after start of interventionPopulation: The number of participants represents the number that completed data to be analyzed for this particular outcome measure.
Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=13 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Soluble Tumor Necrosis Factor Receptor 1 [sTNF-R1] Measured Using High-sensitivity Quantikine Immunoassay Kits
|
0.87 pg/ml
Interval 0.78 to 0.97
|
0.87 pg/ml
Interval 0.78 to 0.97
|
SECONDARY outcome
Timeframe: At 2 weeks after start of interventionInflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=13 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
|
1.6 pg/ml
Interval 1.1 to 2.1
|
1.7 pg/ml
Interval 1.2 to 2.3
|
SECONDARY outcome
Timeframe: At 10 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Inflammatory cytokines (i.e., interleukin 6 \[IL-6\], soluble tumor necrosis factor receptor 1 \[sTNF-R1\], and tumor necrosis factor alpha \[TNF-alpha\]) that have been associated with fatigue during treatment for gastrointestinal cancer and influenced by yoga practice will be measured using high-sensitivity Quantikine immunoassay kits. All samples will be assayed in duplicate and the average of the two measures will be used for data analyses.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=13 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Tumor Necrosis Factor Alpha [TNF-alpha] Measured Using High-sensitivity Quantikine Immunoassay Kits
|
1.01 pg/ml
Interval 0.91 to 1.13
|
1.01 pg/ml
Interval 0.91 to 1.13
|
SECONDARY outcome
Timeframe: At baseline, 8 weeks, 10 weeks and 14 weeks after start of interventionPsychological stress will be assessed by the 10-item PSS. The PSS has 2 factors (stress and counter stress). Scoring scale range from 0 - never, 1 - almost never, 2 - sometimes, 3 - fairly often and 4 - very often. Score range is 0-40. A higher score represents more of the concept being measured.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=22 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=20 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Psychological Stress Assessed by the Perceived Stress Scale (PSS)
Baseline, mean
|
14.7 score on a scale
Standard Error 1.5
|
16.5 score on a scale
Standard Error 1.6
|
|
Psychological Stress Assessed by the Perceived Stress Scale (PSS)
8 weeks
|
11.4 score on a scale
Standard Error 1.8
|
13.7 score on a scale
Standard Error 1.9
|
|
Psychological Stress Assessed by the Perceived Stress Scale (PSS)
10 weeks
|
12.1 score on a scale
Standard Error 1.8
|
12.3 score on a scale
Standard Error 2.1
|
|
Psychological Stress Assessed by the Perceived Stress Scale (PSS)
14 weeks
|
12.5 score on a scale
Standard Error 1.8
|
13.6 score on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: At 0-2 weeks and 8-10 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Psychological stress will be assessed daily with two items from the 4-item PSS that would be on the same factor to optimize internal consistency. Scoring scale range from 1 - never, 2 - rarely, 3 - sometimes, 4 - often and 5 - always. A mean of the participants scores was taken.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=20 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=19 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Psychological Stress Assessed by the PSS (Daily)
0-2 weeks, mean
|
1.34 score on a scale
Standard Error 0.36
|
1.58 score on a scale
Standard Error 0.42
|
|
Psychological Stress Assessed by the PSS (Daily)
8-10 weeks, mean
|
1.69 score on a scale
Standard Error 0.55
|
1.78 score on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: At 0-2 weeks and 8-10 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Regulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=20 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=19 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)
0-2 weeks, mean
|
10.51 score on a scale
Standard Error 0.55
|
9.59 score on a scale
Standard Error 0.66
|
|
Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)
8-10 weeks, mean
|
10.53 score on a scale
Standard Error 0.74
|
10.36 score on a scale
Standard Error 0.84
|
SECONDARY outcome
Timeframe: At baseline, 8 weeks, 10 weeks and 14 weeks after start of interventionPopulation: Numbers may vary based on number of participants that actually completed intervention materials
Regulation of psychological stress will be determined by ratings on four of the seven factors of the Cancer Behavior Inventory, which assess self-efficacy for stress management, coping with treatment-related side-effects, accepting cancer/maintaining positive attitude, and affective regulation. Scale ranged from 1-9 (1 - 3 not at all confident; 4-6 moderately confident and 7-9 totally confident). 4 of the 7 items from the Cancer Behavior Inventory (V2.0) were used with each item's score ranges from 0-50 with higher scores indicating more confidence in the item.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=23 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=20 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Baseline - Stress management
|
34.8 score on a scale
Standard Error 1.4
|
34.2 score on a scale
Standard Error 1.5
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Baseline - Coping with treatment-related side effects
|
33.1 score on a scale
Standard Error 1.8
|
30.6 score on a scale
Standard Error 1.8
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Baseline - Accepting cancer/maintaining positive attitude
|
37.8 score on a scale
Standard Error 1.3
|
39.3 score on a scale
Standard Error 0.9
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
Baseline - Affective regulation
|
28.2 score on a scale
Standard Error 1.6
|
29.9 score on a scale
Standard Error 1.6
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
8 weeks - Stress management
|
38.1 score on a scale
Standard Error 1.3
|
38.6 score on a scale
Standard Error 1.9
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
8 weeks - Coping with treatment-related side effects
|
37.1 score on a scale
Standard Error 1.7
|
35.4 score on a scale
Standard Error 2.1
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
8 weeks - Accepting cancer/maintaining positive attitude
|
40.4 score on a scale
Standard Error 1.2
|
38.9 score on a scale
Standard Error 1.6
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
8 weeks - Affective regulation
|
29.8 score on a scale
Standard Error 2.1
|
31.8 score on a scale
Standard Error 2.1
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
10 weeks - Stress management
|
38.2 score on a scale
Standard Error 1.1
|
38.5 score on a scale
Standard Error 1.6
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
10 weeks - Coping with treatment-related side effects
|
36.8 score on a scale
Standard Error 1.6
|
37.5 score on a scale
Standard Error 2.3
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
10 weeks - Accepting cancer/maintaining positive attitude
|
40.6 score on a scale
Standard Error 0.9
|
40.6 score on a scale
Standard Error 1.6
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
10 weeks - Affective regulation
|
30.1 score on a scale
Standard Error 2.2
|
33.1 score on a scale
Standard Error 2.3
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
14 weeks - Stress management
|
39.2 score on a scale
Standard Error 1.4
|
40.1 score on a scale
Standard Error 1.1
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
14 weeks - Coping with treatment-related side effects
|
37.0 score on a scale
Standard Error 1.7
|
38.4 score on a scale
Standard Error 1.5
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
14 weeks - Accepting cancer/maintaining positive attitude
|
40.0 score on a scale
Standard Error 1.2
|
41.1 score on a scale
Standard Error 1.0
|
|
Regulation of Psychological Stress Assessed Using the Cancer Behavior Inventory
14 weeks - Affective regulation
|
32.3 score on a scale
Standard Error 2.1
|
34.0 score on a scale
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Up 10 weeks after start of interventionParticipants will keep daily paper logs of their home practice. In addition, one item will ask via the daily automated survey how many minutes participants practiced the intervention that day for two weeks after completion of the intervention.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=16 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=14 Participants
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Minutes of Home Practice Completed
|
11.2 minutes
Standard Error 1.9
|
12.1 minutes
Standard Error 6.3
|
SECONDARY outcome
Timeframe: At baseline, 2 weeks, 8 weeks, 10 weeks and 14 weeks after start of interventionPopulation: Four in-person interventions were performed per participant at weeks 2, 4, 6, and 8. A total of 92 interventions were available for completion for Group I. A total of 84 interventions were available for completion for Group II.
Percent of all assessments completed and timeliness of completion will be tracked.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=92 total of interventions available
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=84 total of interventions available
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Percent of Planned In Person Intervention Sessions Attended
|
68 total interventions actually completed
|
72 total interventions actually completed
|
SECONDARY outcome
Timeframe: At 14 weeks after start of interventionPopulation: As per the protocol, this outcome was intended to be combined after all other data collection is complete to solicit feedback as a group on the acceptability of data collection methods, the participants' experience with both the interventions (e.g., expected efficacy, what was useful), and barriers and facilitators to home practice. It was not intended to be separated but as overall feedback.
Qualitative feedback will be assessed with a semi-structured interview conducted after completion of all assessments. Qualitative information gained will enrich quantitative results and inform the protocol of a larger trial.
Outcome measures
| Measure |
Group I (Yoga Skills Training)
n=43 Participants
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participants With Successful Qualitative Data Collection
|
30 Participants
|
—
|
Adverse Events
Group I (Yoga Skills Training)
Serious events: 4 serious events
Other events: 1 other events
Deaths: 2 deaths
Group II (Attention Control)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Group I (Yoga Skills Training)
n=23 participants at risk
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 participants at risk
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
General disorders
Death
|
8.7%
2/23 • Number of events 2 • Over 8 weeks
|
9.5%
2/21 • Number of events 2 • Over 8 weeks
|
|
Gastrointestinal disorders
Bowel perforation
|
4.3%
1/23 • Number of events 1 • Over 8 weeks
|
0.00%
0/21 • Over 8 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • Number of events 1 • Over 8 weeks
|
0.00%
0/21 • Over 8 weeks
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/23 • Over 8 weeks
|
4.8%
1/21 • Number of events 1 • Over 8 weeks
|
Other adverse events
| Measure |
Group I (Yoga Skills Training)
n=23 participants at risk
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
Actigraphy Assessment: Ancillary studies
|
Group II (Attention Control)
n=21 participants at risk
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8.
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
Daily Survey Administration: Ancillary studies
Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
Actigraphy Assessment: Ancillary studies
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • Over 8 weeks
|
4.8%
1/21 • Number of events 1 • Over 8 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • Over 8 weeks
|
4.8%
1/21 • Number of events 1 • Over 8 weeks
|
|
Gastrointestinal disorders
Toothache
|
4.3%
1/23 • Number of events 1 • Over 8 weeks
|
0.00%
0/21 • Over 8 weeks
|
Additional Information
Study coordinator
Wake Forest University Health Sciences
Phone: 336-716-9055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place